Desunin 2000 IU Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

Viatris Healthcare Limited

ATC code:

A11C

INN (International Name):

Colecalciferol

Pharmaceutical form:

Tablet

Therapeutic area:

VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO

Authorization status:

Not marketed

Authorization date:

2015-12-11

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
DESUNIN 2000 IU TABLETS
Colecalciferol (Vitamin D
3
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Desunin is and what it is used for
2.
What you need to know before you take Desunin
3.
How to take Desunin
4.
Possible side effects
5.
How to store Desunin
6.
Contents of the pack and other information
1.
WHAT DESUNIN IS AND WHAT IT IS USED FOR
Desunin contains vitamin D
3
which regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.
Desunin is used to treat vitamin D
3
deficiency in adults and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESUNIN
_ _
DO NOT TAKE DESUNIN
-
if you are allergic to colecalciferol or any of the other ingredients
of this medicine (listed in
section 6).
-
if you have hypercalcaemia (increased levels of calcium in the blood)
or hypercalciuria
(increased levels of calcium in the urine).
-
if you have hypervitaminosis D (increased levels of vitamin D in the
blood).
-
if you have kidney stones.
If any of the above applies to you, talk to your doctor or pharmacist
before taking Desunin.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Desunin
-
if you suffer from sarcoidosis (a special type of connective tissue
disease that affects the lungs,
skin and joints).
-
when using other drugs containing vitamin D.
-
if you have kidney problems or have had kidney stones.
OTHER MEDICINES AND DESUNIN
Tell your doctor if you are taking, have recently taken or

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2023
CRN00DFNK
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desunin 2000 IU Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains colecalciferol (vitamin D
3
) 2000 IU (equivalent to 50 microgram vitamin D
3
).
Excipients with known effect:
Each tablet contains isomalt 227.5 mg and sucrose 4.2 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to light yellow, oblong, 14 mm long.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of vitamin D deficiency in adults and adolescents.
Vitamin D deficiency is defined as serum levels of
25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: One tablet per day.
The dose should be adjusted dependent upon desirable serum levels of
25-hydroxycolecalciferol (25(OH)D), the severity of the
disease and the patient" s response to treatment.
The daily dose should not exceed 4000 IU (two tablets per day).
_Pediatric population_
The safety and efficacy of Desunin in children under 12 years have not
been established.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
Desunin should be used with caution in patients with renal impairment
(see section 4.4).
Method of administration
The tablets can be swallowed whole or crushed. The tablets can be
taken with food.
4.3 CONTRAINDICATIONS
- Diseases and/or conditions resulting in hypercalcaemia or
hypercalciuria
- Nephrolithiasis
- Nephrocalcinosis
- Hypervitaminosis D
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Health Products Regulatory Authority
30 June 2023
CRN00DFNK
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Desunin should be prescribed with caution to patients suffering from
sarcoidosis due to risk of increased metabolism of
vitamin D into its active form. These patients should be monitored
with regard to the calcium content in